The purpose of this study is to learn whether a procedure called Proximal Splenic Artery Embolization (PSAE) can lower the need for repeat fluid drainage in adults with cirrhosis and a buildup of fluid in the abdomen (ascites) that is no longer controlled by water pills and diet. Participants in this study have already been told that a standard procedure called Trans jugular Intrahepatic Portosystemic Shunt (TIPS) is not a safe option for them. The main objectives this study aims to answer are:
* Does PSAE lower how often participants need paracentesis, the procedure used to drain fluid from the abdomen? * Does PSAE lower the total amount of fluid drained each month? * Does PSAE change the pressure inside the liver's veins and the blood flow in the liver and spleen? * Does PSAE improve day-to-day symptoms, quality of life, strength, and the ability to do usual activities? * What side effects or complications happen with PSAE in this group of people?
Participants will:
* Undergo one PSAE procedure, during which small coils and/or plugs are placed in the artery that supplies the spleen to slow its blood flow * Have a pressure measurement taken in the liver's veins right before and right after the procedure, with a repeat measurement at 1 month * Attend follow-up visits at 1, 3, and 6 months that include blood tests, ultrasounds, symptoms and quality-of-life questionnaires, and a review of any paracentesis sessions since the last visit * Have a Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) and an ultrasound of the liver and spleen blood vessels at the start of the study and again at 6 months
Age ≥ 18 years at the time of informed consent.
Decompensated cirrhosis confirmed by clinical, laboratory, radiographic, or histologic criteria.
Portal hypertension of sinusoidal origin. Pre-sinusoidal (e.g., idiopathic non-cirrhotic portal hypertension, schistosomiasis) and post-sinusoidal (e.g., Budd-Chiari syndrome, right-heart failure, constrictive pericarditis) etiologies are excluded.
Refractory or recurrent ascites defined as ascites not controlled by maximum tolerated diuretic therapy (spironolactone ≤ 400 mg/day + furosemide ≤ 160 mg/day, or maximum tolerated doses below these limits) and sodium restriction, or diuretic-intractable due to diuretic-induced complications.
Age < 18 years.
Unable to provide informed consent and without an appropriate legally authorized representative.
Pre-sinusoidal or post-sinusoidal portal hypertension (e.g., extrahepatic portal vein thrombosis, idiopathic non-cirrhotic portal hypertension, schistosomiasis, Budd-Chiari syndrome, hepatic sinusoidal obstruction syndrome, constrictive pericarditis, right-heart failure).
Main portal vein thrombosis, splenic vein thrombosis, or superior mesenteric vein thrombosis on screening imaging.
Single group
Proximal Splenic Artery Embolization
DeviceA one-time transcatheter arterial procedure performed under moderate sedation or monitored anesthesia care. Common femoral arterial access is obtained under ultrasound guidance, and a catheter is advanced into the splenic artery. Embolic coils and/or vascular plugs, cleared for peripheral vascular embolization, are deployed to achieve angiographic cessation of antegrade flow in the proximal splenic artery, while collateral flow to the spleen is preserved. Oral antibiotic prophylaxis is given for 7 days following the procedure.
Change in Monthly Frequency of Large-Volume Paracentesis Sessions
Change from the mean monthly number of large-volume paracentesis (LVP) sessions during the 3-month period before PSAE to the number of sessions in the 28-day window ending at the Month 6 visit, abstracted from clinical and procedural records.
Change in Monthly Volume of Ascites Fluid Drained
Change from the mean monthly total volume (in liters) of ascites fluid drained during the 3-month period before PSAE to the total volume drained in the 28-day window ending at the Month-6 visit, abstracted from clinical and procedural records
Proportion of Participants with a Major Procedure-Related Adverse Event
Proportion of participants experiencing at least one procedure-related adverse event graded Society of Interventional Radiology (SIR) Adverse Event Classification System (2017) grade 3 or higher, cross-referenced to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 grading
Change in Hepatic Venous Pressure Gradient at Month 1
Change in HVPG, measured in mmHg by trans jugular catheterization and calculated as wedged hepatic venous pressure minus free hepatic venous pressure, from the pre-embolization measurement on the day of PSAE to the Month-1 follow-up measurement
Change in Hepatic Artery Resistive Index (RI)
Change in hepatic artery resistive index, measured by Doppler ultrasound and calculated as (difference between peak systolic velocity and end-diastolic velocity) divided by peak systolic velocity
Change in Daily Diuretic Dose
Change in daily diuretic dose, expressed in spironolactone-equivalent and furosemide-equivalent units
Time to Resolution of Large-Volume Paracentesis Dependence
Time from PSAE to the first 60-day interval without a large-volume paracentesis session, analyzed with death and liver transplantation treated as competing events
Change in Ascites-Q Total Score
Change in Ascites-Q Total Score, a validated 11-item ascites-specific symptom questionnaire, reported on 0-100 scale where higher score indicates greater ascites-related symptom burden
Change in Ascites-Q Subscale Scores
Change in individual Ascites-Q item-level scores across 11 symptom domains (including abdominal fullness, early satiety, dyspnea, and reduced mobility), each rated from 0 to 5, with higher scores indicating greater symptom burden
Change in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Domain Scores
Change in PROMIS-29 Profile version 2.0 T-scores across seven domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain interference) and the single-item pain intensity score. T-scores have a mean of 50, and Standard deviation of 10; higher scores indicate more of the domain being measured (example: a higher Physical Education score indicates better function, while a higher anxiety score indicates more anxiety)
Change in Liver Frailty Index
Change in Liver Frailty Index, a composite score derived from grip strength, time chair stands, and balance testing. Scores below 3.2 indicate robust status, 3.2 to below 4.5 indicate prefail status, and 4.5 or higher indicate frail status
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Massachusetts General Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
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